Handbook of Modern Pharmaceutical Analysis: Volume 3 - Rilegato

Rilegato

ISBN 10: 0120455552 ISBN 13: 9780120455553

Casa editrice: Academic Pr, 2001

Riassunto

This book describes the role modern pharmaceutical analysis plays in the development of new drugs. Detailed information is provided as to how the quality of drug products is assured from the point of discovery until the patient uses the drug. Coverage includes state-of-the-art topics such as analytics for combinatorial chemistry and high-throughput screening, formulation development, stability studies, international regulatory aspects and documentation, and future technologies that are likely to impact the field. Emphasis is placed on current, easy-to-follow methods that readers can apply in their laboratories.

No book has effectively replaced the very popular text, Pharmaceutical Analysis, that was edited in the 1960s by Tak Higuchi. This book will fill that gap with an up-to-date treatment that is both handy and authoritative.

Su questo libro

Informazioni sugli autori

Satinder Ahuja is a leading expert on water quality improvement. He earned his PhD in analytical chemistry from the University of the Sciences in Philadelphia. He worked for Novartis Corp. in various leadership positions for over 25 years and taught as an adjunct professor at Pace University for over 10 years. As president of Ahuja Consulting, he advises on water quality issues relating to chemicals and pharmaceuticals. A member of the executive committee of the Rivers of the World Foundation (ROW), Dr. Ahuja has organized numerous global symposia on improving water quality, including presentations for the American Chemical Society and UNESCO. Dr. Ahuja has published numerous papers and more than 25 books. His latest books are Contaminants in Our Water (ACS, 2020); Evaluating Water Quality to Prevent Future Disasters (Elsevier, 2019); Advances in Water Purification Techniques (Elsevier, 2019); and Chemistry and Water (Elsevier, 2017).

Stephen Scypinski obtained his Ph.D. in analytical chemistry from Seton Hall University. He is director of analytical chemistry research and development department at R.W. Johnson Pharmaceutical Research Institute.

Dalla quarta di copertina

This authoratative and practical handbook highlights the role of analytical R&D through its organization of chapters on a process-driven basis.
Includes coverage of:
* Regulatory requirements and compliance issues
* Material from the International Conference on Harmonization
* New drug discovery and optimization processes based on combinatorial chemistry coupled with high-througput screening
* Processes involved in developing successful formulations, including new delivery systems
* The nuts and bolts of pharmaceutical analysis that generally constitutes compendial testing, method developments, setting specifications, stability studies, and method validation

Additionally, the importance of excellent analytical documentation is discussed in regard to monitoring and ensuring the identity, purity, stability, and consistency of drug substance and dosage forms used during preclinical, clinical, and marketing phases in accordance with governing regulatory guidance and policies. New analytical platforms such as microfabricated electrophoresis devices are also reviewed and their applications to analysis of proteins, peptides, DNA, and small molecules, including chiral separations, are highlighted.|This authoratative and practical handbook highlights the role of analytical R&D through its organization of chapters on a process-driven basis.
Includes coverage of:
* Regulatory requirements and compliance issues
* Material from the International Conference on Harmonization
* New drug discovery and optimization processes based on combinatorial chemistry coupled with high-througput screening
* Processes involved in developing successful formulations, including new delivery systems
* The nuts and bolts of pharmaceutical analysis that generally constitutes compendial testing, method developments, setting specifications, stability studies, and method validation

Additionally, the importance of excellent analytical documentation is discussed in regard to monitoring and ensuring the identity, purity, stability, and consistency of drug substance and dosage forms used during preclinical, clinical, and marketing phases in accordance with governing regulatory guidance and policies. New analytical platforms such as microfabricated electrophoresis devices are also reviewed and their applications to analysis of proteins, peptides, DNA, and small molecules, including chiral separations, are highlighted.

Dettagli dell'edizione

• Editore: Academic Pr
• Data di pubblicazione: 2001
• Lingua: Inglese
• ISBN 10: 0120455552
• ISBN 13: 9780120455553
• Rilegatura: Copertina rigida
• Numero edizione: 1
• Numero di pagine: 566
• Redattore: Ahuja Satinder, Scypinski Stephen
• Contatto del produttore: non disponibile
• Persona responsabile: non disponibile